Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)
FDA device recall Z-2642-2010 · posted 2010-10-01 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type.
- Action taken
- Asked consignees to return camera heads to correct the labeling.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 217 camera heads
- Distribution
- nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe
- Date initiated
- 2010-08-20
- Date posted
- 2010-10-01
- Date terminated
- 2012-09-27
- Location
- Center Valley, PA
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